Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03053999

Conditions

Multiple Endocrine Neoplasia

Pancreatic Neuroendocrine Tumors

Hyperparathyroidism

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Genome Sequencing

Data Review

Study Details

Brief summary:

The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH) who undergo surgery.

Conditions

Multiple Endocrine Neoplasia

Pancreatic Neuroendocrine Tumors

Hyperparathyroidism

Study ID

NCT03053999

Start date

Oct 9, 2012

Status verified date

Sep, 2019

Completion date

Oct, 2023

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. MEN1 patients who have undergone parathyroidectomy and did not develop PNET.
2. MEN1 patients who have undergone parathyroidectomy and had surgical removal of PNET.

Exclusion Criteria:

N/A

Study Design

Enrollment

53 participants

Anticipated

Interventions and Outcome Measures

Arms

Parathyroidectomy Tissue and Data

Analyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors.

Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels).

Interventions

Genome Sequencing

Analyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors.

Data Review

Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels).

Primary outcome measure

  • Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Genome Sequencing [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Nancy D. Perrier, MD

713-792-6940NPerrier@mdanderson.org

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Sep 12, 2019

Last verified

Sep, 2019

Keywords

  • Multiple Endocrine Neoplasia
  • Pancreatic Neuroendocrine Tumors
  • Hyperparathyroidism
  • HPTH
  • PNET
  • Biomarkers
  • Parathyroidectomy
  • Genome sequencing
  • Data review

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2019-09-12.